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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Mar 2012-April 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(oct-2-en-1-yl)dihydrofuran-2,5-dione
EC Number:
629-679-7
Cas Number:
42482-06-4
Molecular formula:
C12H18O3
IUPAC Name:
3-(oct-2-en-1-yl)dihydrofuran-2,5-dione
Test material form:
other: liquid
Details on test material:
Octenyl Succinic Anhydride, Lot #: 44514821. purity: 99.0%. Source: Gulf Bayport Chemicals LP., Pasadena, TX.
The test substance was stored at room temperature.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Housing: The animals were singly housed in suspended stainless steel caging with mesh floors. Litter paper was placed beneath the cage and was changed at least three times per week.
Animal Room Temperature and Relative Humidity Ranges: 19-23°C and 31-56%, respectively.
Animal Room Air Changes/Hour: 12. Airflow measurements are evaluated regularly.
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 6 or 7 days
Food: Harlan Teklad Global High Fiber Rabbit Diet® #2031. A designated amount of the diet was available to each rabbit (approximately 150 grams/day).
Water: Filtered tap water was supplied ad libitum by an automatic water dispensing system.

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Five-tenths of a milliliter was applied.
Duration of treatment / exposure:
4 hours.
Observation period:
30-60 minutes, 24, 48, and 72 hours, and 7 days.
Number of animals:
3
Details on study design:
Five-tenths of a milliliter of the test substance was applied to one 6cm2 intact dose site on each animal and covered with a 1-inch x 1-inch, 4-ply gauze ad. The pad and entire trunk of each animal were then wrapped with semi-occlusive 3-inch Micropore tape to avoid dislocation of the pad. Elizabethan collars were placed on each rabbit and they were returned to their cages.
After 4 hours of exposure to the test substance, the pads and collars were removed and the test sites were gently cleansed of any residual test substance.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48 h
Score:
3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48 h
Score:
3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
7 d
Score:
0
Max. score:
7
Reversibility:
fully reversible

Any other information on results incl. tables

Evaluation Scale is provided below:

Skin Reaction

Value

Erythema and eschar formation

 

   No erythema

0

   Slight erythema

1

   Well defined erythema

2

   Moderate to severe erythema

3

   Severe erythema to slight eschar formation

4

Edema formation

 

   No edema

0

   Very slight edema

1

   Slight edema

2

   Moderate edema

3

   Severe edema

4

The resulting Primary Dermal Irritation Index (PDII) was classified as follows:

PDII                                                                               Classification

0                                                                                 Non-irritating

> 0 - 2.0                                                                           Slightly irritating

2.1 - 5.0                                                                            Moderately irritating

> 5.0                                                                             Severely irritating

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Under the conditions of this study, octenyl succinic anhydride is considered moderately irritating to the skin. It is classified as Category 2 according to Regulation EC No. 1272/2008